A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence (FP1097-002)

FemmePharma

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence, Urge

Treatments: Drug: oxybutynin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00749632

FP1097-002

Details and patient eligibility

About

The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females 18 to 75 years of age
• Has reported symptoms of urge urinary incontinence/overactive bladder

Exclusion criteria

• Is pregnant or lactating
• Has had lower urinary tract surgery within 6 months prior to Screening
• Has a history of urinary retention

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

1

Active Comparator group

Treatment:

Drug: oxybutynin

Drug: oxybutynin

Drug: oxybutynin

2

Active Comparator group

Treatment:

Drug: oxybutynin

Drug: oxybutynin

Drug: oxybutynin

3

Active Comparator group

Treatment:

Drug: oxybutynin

Drug: oxybutynin

Drug: oxybutynin